510(k) K912565
- Device
- MICRO-COLL COLLAGEN WOUND SPRAY
- Applicant
- MICRO-COLL
- 510(k) number
- K912565
- Product code
- MGQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-06-11
- Date received
- 1991-06-11
- Regulation
- 510(k) Premarket Notification
- Classification name
- Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- VINAY K SHARMA
- Address
- 527 Division St. Bangor PA US 18013 18013
FDA Registration Numbers
- 1648579
- 3006784948
- 1646434
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MGQ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171879 | HylaGuard Moisturizing Cream | Founders Science Group, LLC | 2017-10-16 |
| K083024 | HYLATOPIC EMOLLIENT FOAM | Collegium Pharmaceutical Incorporated | 2009-03-27 |
| K041342 | IMPRUV A.I. CREAM WOUND AND SKIN EMULSION | Stiefel Laboratories, Inc. | 2005-07-19 |
| K041268 | SILVERSITE OR CALGITROL | Adri | 2004-09-20 |
| K040019 | SILVERSEAL | Noble Fiber Technologies | 2004-07-23 |
| K040517 | TENDERWET ACTIVE | Medline Industries, Inc. | 2004-03-25 |
| K022587 | MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS | Medtrade Products , Ltd. | 2003-08-22 |
| K024367 | SINCLAIR WOUND AND SKIN EMULSION | Sinclair Pharmaceuticals, Ltd. | 2003-07-28 |
| K024054 | XYLOS XCELL ANTIMICROBIAL DRESSING | Xylos Corporation | 2003-03-07 |
| K022584 | CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING | Cardiotech Intl. | 2002-12-30 |
| K022995 | COLLATEK HYDROGEL | Biocore Medical Technologies, Inc. | 2002-12-02 |
| K013525 | CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) | Coloplast Corp. | 2002-10-04 |
| K020325 | L.A.M. IPM WOUND GEL | L.A.M. Pharmaceutical, Corp. | 2002-04-15 |
| K011994 | ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 | Acrymed, Inc. | 2001-11-08 |
| K010583 | AMBU GEL, HYDROGEL BURN DRESSING | Ambu, Inc. | 2001-05-25 |
Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases